Effects of Dexmedetomidine on Postoperative Cognitive Dysfunction During One-lung Ventilation in Elder Patients

Effects of Dexmedetomidine on Postoperative Cognitive Dysfunction During One-lung Ventilation in Elder Patients -a Single-center, Randomized ,Double-blinded and Controlled Trial

This study is to explore the effects of dexmedetomidine on postoperative cognitive dysfunction during one-lung ventilation in elder patients.

Study Overview

• Status: Unknown
• Conditions: Postoperative Confusion
• Intervention / Treatment: Drug: Induction of anesthesia,midazolam ,sufentanil,etomidate and rocuronium; Drug: Normal saline; Drug: Maintenance of anesthesia , propofol, remifentanil,vecuronium; Drug: Dexmedetomidine

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Written informed consent.
• Ongoing one-lung ventilation surgery.
• American Society of Anesthesiologists class I to III.
• Aged between 55 and 75 years old.
• Body Mass Index between 18 and 25 kg/m2.

Exclusion Criteria:

• Systolic blood pressure more than 180 mmHg or lower than 90 mmHg,diastolic blood pressure more than 110 mmHg or lower than 60 mmHg.
• Serious heart,liver,kidney, pulmonary, and endocrine disease or serious infection.
• Suspected or confirmed difficult airway.
• History of abnormal anesthesia.
• Suspected of malignant hyperthermia.
• Use of sedative and antidepressant drug or serious alcoholism
• Mini-mental State Examination less than 17.
• Highest academic degree below grade 6 in primary schools
• Patients inability to exchange with serious visual and hearing impairment or mental disability.
• History of shock.
• Carotid artery stenosis and central nervous system disease such as stroke, epilepsy.
• Allergic to investigational products or with other contraindication.
• Participated in other study within 30 days .

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Normal saline; Continuous pump infusion of normal saline with identical volume, compared with the low dose and high dose group,until the end of surgery	Drug: Induction of anesthesia,midazolam ,sufentanil,etomidate and rocuronium; Anesthesia induction:midazolam (0.03~0.05 mg/kg), sufentanil(0. 5~0.8 μg/kg), etomidate ( 0.2~0.6mg/kg) and rocuronium(0.6mg/kg); Drug: Normal saline; Continuous pump infusion normal saline with identical volume of dexmedetomidine.; Drug: Maintenance of anesthesia , propofol, remifentanil,vecuronium; Continuous infusion of propofol （3~6 mg/kg/h）, remifentanil （0.05~0.3 μg/kg/min）is required to maintain Entropy within 40~60,Mean Arterial Blood Pressure more than 20% of baseline level , Oxygen Saturation more than 90% , airway pressure less than 40 cm H2O, intermittent injection vecuronium （0.05~0.1mg/kg） as needed to maintain muscle relaxation.
Experimental: High dose group, dexmedetomidine; Continuous pump infusion dexmedetomidine at 1μg/kg for 15 minutes before anesthesia induction ,then continuous pump infusion dexmedetomidine at 0.4μg/kg/h until the end of surgery	Drug: Induction of anesthesia,midazolam ,sufentanil,etomidate and rocuronium; Anesthesia induction:midazolam (0.03~0.05 mg/kg), sufentanil(0. 5~0.8 μg/kg), etomidate ( 0.2~0.6mg/kg) and rocuronium(0.6mg/kg); Drug: Maintenance of anesthesia , propofol, remifentanil,vecuronium; Continuous infusion of propofol （3~6 mg/kg/h）, remifentanil （0.05~0.3 μg/kg/min）is required to maintain Entropy within 40~60,Mean Arterial Blood Pressure more than 20% of baseline level , Oxygen Saturation more than 90% , airway pressure less than 40 cm H2O, intermittent injection vecuronium （0.05~0.1mg/kg） as needed to maintain muscle relaxation.; Drug: Dexmedetomidine; Continuous pump infusion dexmedetomidine at 0.5μg/kg （low dose group）or 1μg/kg （high dose group）for 15 minutes before anesthesia induction，then followed by a continuous pump infusion at 0.2 μg/kg/h（low dose group）or 0.4μg/kg/h（high dose group） until the end of surgery.
Experimental: Low dose group, dexmedetomidine; Continuous pump infusion dexmedetomidine at 0.5μg/kg for 15 minutes before anesthesia induction ,then continuous pump infusion dexmedetomidine at 0.2μg/kg/h until the end of surgery	Drug: Induction of anesthesia,midazolam ,sufentanil,etomidate and rocuronium; Anesthesia induction:midazolam (0.03~0.05 mg/kg), sufentanil(0. 5~0.8 μg/kg), etomidate ( 0.2~0.6mg/kg) and rocuronium(0.6mg/kg); Drug: Maintenance of anesthesia , propofol, remifentanil,vecuronium; Continuous infusion of propofol （3~6 mg/kg/h）, remifentanil （0.05~0.3 μg/kg/min）is required to maintain Entropy within 40~60,Mean Arterial Blood Pressure more than 20% of baseline level , Oxygen Saturation more than 90% , airway pressure less than 40 cm H2O, intermittent injection vecuronium （0.05~0.1mg/kg） as needed to maintain muscle relaxation.; Drug: Dexmedetomidine; Continuous pump infusion dexmedetomidine at 0.5μg/kg （low dose group）or 1μg/kg （high dose group）for 15 minutes before anesthesia induction，then followed by a continuous pump infusion at 0.2 μg/kg/h（low dose group）or 0.4μg/kg/h（high dose group） until the end of surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change in memory	The change in memory will be evaluated by Controlled Oral Word Association Test ,Semantic Fluency test	one day before operation, first day after operation
Cognitive function	Cognitive function will be evaluated by Mini-mentalStateExamination,Digit-Symbol Substitution Test ,Trail Making Test	one day before operation, first day after operation
Postoperative anxiety	Self-evaluation of Depression Symptoms form,Self-Rating Anxiety Scale,Visual analog scales	one day before operation, first day after operation

Secondary Outcome Measures

Outcome Measure	Time Frame
Heart rate	At the moment of entering operating room ,the moment of intubation，prior to one lung ventilation,10 minutes,30 minutes afer one lung ventilation,the end of operation and the moment of leaving the operating room
Bleeding volume	At the beginning of operation,at the end of operation,up to 24 hours
Total volume of fluid	At the beginning of operation,at the end of operation,up to 24 hours
Duration of one lung ventilation	At the beginning of one lung ventilation,at the end of one lung ventilation,an expected average of 3 hours
The total dose of anaesthetic drugs	At the beginning of surgery,at the end of surgery,up to 24 hours
The total dose of analgesic drugs	During perioperative period,up to 7 days
Blood pressure	At the moment of entering operating room ,the moment of intubation，prior to one lung ventilation,10 minutes,30 minutes afer one lung ventilation,the end of operation and the moment of leaving the operating room
Oxygen saturation	At the moment of entering operating room ,the moment of intubation，prior to one lung ventilation,10 minutes,30 minutes afer one lung ventilation,the end of operation and the moment of leaving the operating room
End-tidal carbon dioxide	At the moment of entering operating room ,the moment of intubation，prior to one lung ventilation,10 minutes,30 minutes afer one lung ventilation,the end of operation and the moment of leaving the operating room
Operation duration	At the beginning of surgery,at the end of surgery,up to 24 hours

Collaborators and Investigators

• Sponsor: Tang-Du Hospital

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Anticipated): May 1, 2015
• Study Completion (Anticipated): December 1, 2015

Study Registration Dates

• First Submitted: April 29, 2014
• First Submitted That Met QC Criteria: May 6, 2014
• First Posted (Estimate): May 8, 2014

Study Record Updates

• Last Update Posted (Estimate): July 11, 2014
• Last Update Submitted That Met QC Criteria: July 9, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Postoperative Complications; Neurologic Manifestations; Neurobehavioral Manifestations; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction; Postoperative Cognitive Complications; Confusion; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Cholinergic Antagonists; Cholinergic Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Analgesics, Opioid; Narcotics; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Neuromuscular Agents; Nicotinic Antagonists; Neuromuscular Nondepolarizing Agents; Neuromuscular Blocking Agents; Anesthetics; Remifentanil; Midazolam; Propofol; Dexmedetomidine; Rocuronium; Sufentanil; Etomidate; Vecuronium Bromide
• Other Study ID Numbers: Tangdu sedation